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FDA 510(k)

Broadway 8 Catheter

K-Number: K241768 · 2024-12-19

ApplicantStryker Neurovascular
Decision Date2024-12-19
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Broadway 8 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K241768. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Broadway 8 Catheter?

Broadway 8 Catheter is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Stryker Neurovascular. The 510(k) number is K241768.

When did Broadway 8 Catheter receive FDA 510(k) clearance?

Broadway 8 Catheter received FDA 510(k) clearance on 2024-12-19, under 510(k) number K241768.

Who is the listed applicant for Broadway 8 Catheter?

The FDA 510(k) record lists Stryker Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Broadway 8 Catheter?

The FDA product code for Broadway 8 Catheter is QJP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04195568Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemACTIVE_NOT_RECRUITING

Other records listing Stryker Neurovascular as applicant

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Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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